The development of novel biopharmaceutical compounds typically requires large investments in time and capital to translate scientific discovery into new medicine and to build specialized manufacturing facilities and equipment. Advanced technologies drive biopharmaceutical manufacturing that aligns with research and development, and requires considerable scientific know-how and infrastructure.
Over the past decade, improvements in biopharmaceutical manufacturing provide an ability to create and maintain market access through scalable and flexible operations, controlled costs, and high quality. In recent years the industry has increasingly turned its attention toward improvements in manufacturing technologies. Emerging technologies are generating further changes across the biopharmaceutical workforce and impacting manufacturers' collaboration strategies and their choices of facility locations.
The past decade has seen a significant shift in the nature of the products being manufactured and sold by the innovative biopharmaceutical industry. The global biopharmaceutical portfolio of today reflects a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise of treatments for many orphan diseases. These development trends provide for biopharmaceutical products with extremely limited production runs, highly specific manufacturing requirements, and genotype-specific products. The on-going shift in the product mix provides a need for continuous improvement of the efficiency and effectiveness of production biopharmaceutical manufacturing.
Biologic medicines such as vaccines are complex molecules made by or from living cells and are often infused or injected. As such, they require highly specialized manufacturing, special storage and handling, and a tightly controlled, high quality manufacturing and distribution network to ensure safety and effectiveness. Developments are also observed with regard to orphan drugs, i.e., drugs aimed at diseases with patient populations of under 200,000, and there has been a steady increase over the past decade. Furthermore, manufacturers are increasingly focusing on more complex diseases for which there are few or no effective treatments. New treatments for these diseases are characterized by small volume products. Orphan drugs have created the need for manufacturing flexibility and the ability to use equipment, and supplies more efficiently and for more than one product because of their relatively small volumes. Additionally, orphan drugs have put pressure on manufacturing volume management, as production processes can often yield larger batches than the required volumes.
Another important trend within biopharmaceuticals is the emergence of personalized medicine; products that target a specific population of patients. Over time, as patient-level personalized medicines are introduced, manufacturing and product supply complexity will likely increase. Furthermore, manufacturing processes will need to accommodate small or scale batch specificity.
These drug portfolio trends have contributed to an increase in the number and complexity of products being manufactured and sold. They have resulted in greater product variety and increased occurrences of small-volume runs, which require frequent changeovers and may necessitate equipment reconfigurations and updates. Additionally, the new medicines have increased the need for more complex manufacturing processes, more advanced equipment, and cold chain or controlled storage. Overall, these drug portfolio trends indicate that there is a need for improved manufacturing creating flexibility with uncompromised quality, while creating operating efficiencies that can help reduce costs.